Meta-Analysis of Effects of Bivalirudin Versus Heparin on Myocardial Ischemic and Bleeding Outcomes After Percutaneous Coronary Intervention
Bivalirudin is an alternative to unfractionated heparin (UFH) anticoagulation during percutaneous coronary intervention. Previously, we have reported clinical benefit on major bleeding in favor of bivalirudin compared with UFH monotherapy but inconclusive results on mortality. Controversial data hav...
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| Veröffentlicht in: | The American journal of cardiology 2016-04, Vol.117 (8), p.1256-1266 |
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| creator | Barria Perez, Alberto E., MD Rao, Sunil V., MD Jolly, Sanjit J., MD, MSc Pancholy, Samir B., MD Plourde, Guillaume, MS Rimac, Goran, MS Poirier, Yann, MS Costerousse, Olivier, PhD Bertrand, Olivier F., MD, PhD |
| description | Bivalirudin is an alternative to unfractionated heparin (UFH) anticoagulation during percutaneous coronary intervention. Previously, we have reported clinical benefit on major bleeding in favor of bivalirudin compared with UFH monotherapy but inconclusive results on mortality. Controversial data have been reported in the last 2 years. We conducted an updated meta-analysis including randomized trials and observational studies, which evaluated ischemic and bleeding outcomes for bivalirudin compared with UFH-only during percutaneous coronary intervention. We included 18 observational studies and 12 randomized trials published from 2003 to 2015. Primary outcomes were major adverse cardiovascular events within 30 days including death, myocardial infarction, and urgent revascularization and stent thrombosis, major bleeding, and transfusion. Overall, we found a significant risk reduction with bivalirudin for major bleeding (odds ratio [OR] 0.59, 95% confidence interval [CI] 0.49 to 0.71, p 60 IU/kg and independent of radial access. In conclusion, compared with UFH monotherapy, bivalirudin remains associated with less bleeding risk but higher stent thrombosis risk. Further study remains required to define its role in current antithrombotic armamentarium. |
| doi_str_mv | 10.1016/j.amjcard.2016.01.015 |
| format | Article |
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Previously, we have reported clinical benefit on major bleeding in favor of bivalirudin compared with UFH monotherapy but inconclusive results on mortality. Controversial data have been reported in the last 2 years. We conducted an updated meta-analysis including randomized trials and observational studies, which evaluated ischemic and bleeding outcomes for bivalirudin compared with UFH-only during percutaneous coronary intervention. We included 18 observational studies and 12 randomized trials published from 2003 to 2015. Primary outcomes were major adverse cardiovascular events within 30 days including death, myocardial infarction, and urgent revascularization and stent thrombosis, major bleeding, and transfusion. Overall, we found a significant risk reduction with bivalirudin for major bleeding (odds ratio [OR] 0.59, 95% confidence interval [CI] 0.49 to 0.71, p <0.0001) and for transfusion (OR 0.79, 95% CI 0.66 to 0.95, p = 0.01) and similar risk for major adverse cardiovascular events (OR 0.98, 95% CI 0.86 to 1.12, p = 0.80). However, there was a substantial increased risk of stent thrombosis associated with bivalirudin (OR 1.52, 95% CI 1.11 to 2.08, p = 0.009). No impact on mortality was found. Meta-regression analyses on major bleeding suggested that bivalirudin was more effective than UFH at doses >60 IU/kg and independent of radial access. In conclusion, compared with UFH monotherapy, bivalirudin remains associated with less bleeding risk but higher stent thrombosis risk. Further study remains required to define its role in current antithrombotic armamentarium.</description><identifier>ISSN: 0002-9149</identifier><identifier>EISSN: 1879-1913</identifier><identifier>DOI: 10.1016/j.amjcard.2016.01.015</identifier><identifier>PMID: 26899489</identifier><identifier>CODEN: AJCDAG</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Acute coronary syndromes ; Antithrombins - adverse effects ; Antithrombins - therapeutic use ; Bias ; Cardiology ; Cardiovascular ; Clinical outcomes ; Confidence intervals ; Diabetes ; Fibrinolytic Agents - adverse effects ; Fibrinolytic Agents - therapeutic use ; Global Health ; Heart attacks ; Heparin - adverse effects ; Heparin - therapeutic use ; Hirudins - adverse effects ; Humans ; Hypothesis testing ; Incidence ; Meta-analysis ; Mortality ; Myocardial Ischemia - therapy ; Peptide Fragments - adverse effects ; Peptide Fragments - therapeutic use ; Percutaneous Coronary Intervention ; Postoperative Hemorrhage - chemically induced ; Postoperative Hemorrhage - epidemiology ; Recombinant Proteins - adverse effects ; Recombinant Proteins - therapeutic use ; Studies ; Thrombosis ; Thrombosis - prevention & control</subject><ispartof>The American journal of cardiology, 2016-04, Vol.117 (8), p.1256-1266</ispartof><rights>Elsevier Inc.</rights><rights>2016 Elsevier Inc.</rights><rights>Copyright © 2016 Elsevier Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited Apr 15, 2016</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c448t-8016bb4bee71eb3ebcddb3720a6557d1307e89a51d02c393e996e7073bbee2643</citedby><cites>FETCH-LOGICAL-c448t-8016bb4bee71eb3ebcddb3720a6557d1307e89a51d02c393e996e7073bbee2643</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1777266731?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976,64364,64366,64368,72218</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26899489$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Barria Perez, Alberto E., MD</creatorcontrib><creatorcontrib>Rao, Sunil V., MD</creatorcontrib><creatorcontrib>Jolly, Sanjit J., MD, MSc</creatorcontrib><creatorcontrib>Pancholy, Samir B., MD</creatorcontrib><creatorcontrib>Plourde, Guillaume, MS</creatorcontrib><creatorcontrib>Rimac, Goran, MS</creatorcontrib><creatorcontrib>Poirier, Yann, MS</creatorcontrib><creatorcontrib>Costerousse, Olivier, PhD</creatorcontrib><creatorcontrib>Bertrand, Olivier F., MD, PhD</creatorcontrib><title>Meta-Analysis of Effects of Bivalirudin Versus Heparin on Myocardial Ischemic and Bleeding Outcomes After Percutaneous Coronary Intervention</title><title>The American journal of cardiology</title><addtitle>Am J Cardiol</addtitle><description>Bivalirudin is an alternative to unfractionated heparin (UFH) anticoagulation during percutaneous coronary intervention. Previously, we have reported clinical benefit on major bleeding in favor of bivalirudin compared with UFH monotherapy but inconclusive results on mortality. Controversial data have been reported in the last 2 years. We conducted an updated meta-analysis including randomized trials and observational studies, which evaluated ischemic and bleeding outcomes for bivalirudin compared with UFH-only during percutaneous coronary intervention. We included 18 observational studies and 12 randomized trials published from 2003 to 2015. Primary outcomes were major adverse cardiovascular events within 30 days including death, myocardial infarction, and urgent revascularization and stent thrombosis, major bleeding, and transfusion. Overall, we found a significant risk reduction with bivalirudin for major bleeding (odds ratio [OR] 0.59, 95% confidence interval [CI] 0.49 to 0.71, p <0.0001) and for transfusion (OR 0.79, 95% CI 0.66 to 0.95, p = 0.01) and similar risk for major adverse cardiovascular events (OR 0.98, 95% CI 0.86 to 1.12, p = 0.80). However, there was a substantial increased risk of stent thrombosis associated with bivalirudin (OR 1.52, 95% CI 1.11 to 2.08, p = 0.009). No impact on mortality was found. Meta-regression analyses on major bleeding suggested that bivalirudin was more effective than UFH at doses >60 IU/kg and independent of radial access. In conclusion, compared with UFH monotherapy, bivalirudin remains associated with less bleeding risk but higher stent thrombosis risk. Further study remains required to define its role in current antithrombotic armamentarium.</description><subject>Acute coronary syndromes</subject><subject>Antithrombins - adverse effects</subject><subject>Antithrombins - therapeutic use</subject><subject>Bias</subject><subject>Cardiology</subject><subject>Cardiovascular</subject><subject>Clinical outcomes</subject><subject>Confidence intervals</subject><subject>Diabetes</subject><subject>Fibrinolytic Agents - adverse effects</subject><subject>Fibrinolytic Agents - therapeutic use</subject><subject>Global Health</subject><subject>Heart attacks</subject><subject>Heparin - adverse effects</subject><subject>Heparin - therapeutic use</subject><subject>Hirudins - adverse effects</subject><subject>Humans</subject><subject>Hypothesis testing</subject><subject>Incidence</subject><subject>Meta-analysis</subject><subject>Mortality</subject><subject>Myocardial Ischemia - therapy</subject><subject>Peptide Fragments - adverse effects</subject><subject>Peptide Fragments - therapeutic use</subject><subject>Percutaneous Coronary Intervention</subject><subject>Postoperative Hemorrhage - chemically induced</subject><subject>Postoperative Hemorrhage - epidemiology</subject><subject>Recombinant Proteins - adverse effects</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>Studies</subject><subject>Thrombosis</subject><subject>Thrombosis - prevention & control</subject><issn>0002-9149</issn><issn>1879-1913</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFUk1v1DAQjRCILoWfALLEhUsWO07i-ALarkq7Uqsi8XG1HGcCDom92MlK-x_40UyaBaRekEayR37vjWfeJMlLRteMsvJtt9ZDZ3Ro1hmma8owikfJilVCpkwy_jhZUUqzVLJcniXPYuwwZawonyZnWVlJmVdylfy6hVGnG6f7Y7SR-JZcti2Y8f56YQ-6t2FqrCNfIcQpkmvY64Cpd-T26Of6VvdkF813GKwh2jXkogdAxjdyN43GDxDJph0hkI8QzDRqBx51tj54p8OR7By-HcCN1rvnyZNW9xFenM7z5MuHy8_b6_Tm7mq33dykJs-rMa2w4brOawDBoOZQm6apucioLotCNIxTAZXUBWtoZrjkIGUJggpeIyUrc36evFl098H_nCCOarDRQN8vn1NMCIRXecUR-voBtPNTwHEtqKwsBWeIKhaUCT7GAK3aBztge4pRNdulOnWyS812KcowCuS9OqlP9QDNX9YffxDwfgEAjuNgIahoLDiDAw7okmq8_W-Jdw8UTG-dNbr_AUeI_7pRMVNUfZp3Zl4ZVnLKuKD8NzQ7vyk</recordid><startdate>20160415</startdate><enddate>20160415</enddate><creator>Barria Perez, Alberto E., MD</creator><creator>Rao, Sunil V., MD</creator><creator>Jolly, Sanjit J., MD, MSc</creator><creator>Pancholy, Samir B., MD</creator><creator>Plourde, Guillaume, MS</creator><creator>Rimac, Goran, MS</creator><creator>Poirier, Yann, MS</creator><creator>Costerousse, Olivier, PhD</creator><creator>Bertrand, Olivier F., MD, PhD</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>M7Z</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20160415</creationdate><title>Meta-Analysis of Effects of Bivalirudin Versus Heparin on Myocardial Ischemic and Bleeding Outcomes After Percutaneous Coronary Intervention</title><author>Barria Perez, Alberto E., MD ; Rao, Sunil V., MD ; Jolly, Sanjit J., MD, MSc ; Pancholy, Samir B., MD ; Plourde, Guillaume, MS ; Rimac, Goran, MS ; Poirier, Yann, MS ; Costerousse, Olivier, PhD ; Bertrand, Olivier F., MD, PhD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c448t-8016bb4bee71eb3ebcddb3720a6557d1307e89a51d02c393e996e7073bbee2643</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Acute coronary syndromes</topic><topic>Antithrombins - 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Academic</collection><jtitle>The American journal of cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Barria Perez, Alberto E., MD</au><au>Rao, Sunil V., MD</au><au>Jolly, Sanjit J., MD, MSc</au><au>Pancholy, Samir B., MD</au><au>Plourde, Guillaume, MS</au><au>Rimac, Goran, MS</au><au>Poirier, Yann, MS</au><au>Costerousse, Olivier, PhD</au><au>Bertrand, Olivier F., MD, PhD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Meta-Analysis of Effects of Bivalirudin Versus Heparin on Myocardial Ischemic and Bleeding Outcomes After Percutaneous Coronary Intervention</atitle><jtitle>The American journal of cardiology</jtitle><addtitle>Am J Cardiol</addtitle><date>2016-04-15</date><risdate>2016</risdate><volume>117</volume><issue>8</issue><spage>1256</spage><epage>1266</epage><pages>1256-1266</pages><issn>0002-9149</issn><eissn>1879-1913</eissn><coden>AJCDAG</coden><abstract>Bivalirudin is an alternative to unfractionated heparin (UFH) anticoagulation during percutaneous coronary intervention. Previously, we have reported clinical benefit on major bleeding in favor of bivalirudin compared with UFH monotherapy but inconclusive results on mortality. Controversial data have been reported in the last 2 years. We conducted an updated meta-analysis including randomized trials and observational studies, which evaluated ischemic and bleeding outcomes for bivalirudin compared with UFH-only during percutaneous coronary intervention. We included 18 observational studies and 12 randomized trials published from 2003 to 2015. Primary outcomes were major adverse cardiovascular events within 30 days including death, myocardial infarction, and urgent revascularization and stent thrombosis, major bleeding, and transfusion. Overall, we found a significant risk reduction with bivalirudin for major bleeding (odds ratio [OR] 0.59, 95% confidence interval [CI] 0.49 to 0.71, p <0.0001) and for transfusion (OR 0.79, 95% CI 0.66 to 0.95, p = 0.01) and similar risk for major adverse cardiovascular events (OR 0.98, 95% CI 0.86 to 1.12, p = 0.80). However, there was a substantial increased risk of stent thrombosis associated with bivalirudin (OR 1.52, 95% CI 1.11 to 2.08, p = 0.009). No impact on mortality was found. Meta-regression analyses on major bleeding suggested that bivalirudin was more effective than UFH at doses >60 IU/kg and independent of radial access. In conclusion, compared with UFH monotherapy, bivalirudin remains associated with less bleeding risk but higher stent thrombosis risk. Further study remains required to define its role in current antithrombotic armamentarium.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>26899489</pmid><doi>10.1016/j.amjcard.2016.01.015</doi><tpages>11</tpages></addata></record> |
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| subjects | Acute coronary syndromes Antithrombins - adverse effects Antithrombins - therapeutic use Bias Cardiology Cardiovascular Clinical outcomes Confidence intervals Diabetes Fibrinolytic Agents - adverse effects Fibrinolytic Agents - therapeutic use Global Health Heart attacks Heparin - adverse effects Heparin - therapeutic use Hirudins - adverse effects Humans Hypothesis testing Incidence Meta-analysis Mortality Myocardial Ischemia - therapy Peptide Fragments - adverse effects Peptide Fragments - therapeutic use Percutaneous Coronary Intervention Postoperative Hemorrhage - chemically induced Postoperative Hemorrhage - epidemiology Recombinant Proteins - adverse effects Recombinant Proteins - therapeutic use Studies Thrombosis Thrombosis - prevention & control |
| title | Meta-Analysis of Effects of Bivalirudin Versus Heparin on Myocardial Ischemic and Bleeding Outcomes After Percutaneous Coronary Intervention |
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